FDA Panel Urges Approval of Hepatitis C Drug

In an18-0 vote, an FDA advisory panel recommended approval of the drug boceprevir to treat hepatitis C.

Panel members called boceprevir, manufactured by Merck & Co., a weapon in the fight against chronic hepatitis C virus (HCV) genotype 1 infection. Chronic HCV genotype 1 infection is the most common form of hepatitis in the U.S. and also the most difficult to treat.

If approved by the FDA, boceprevir will have the brand name Victrelis.

Boceprevir is an antiviral medication called a protease inhibitor that has proven effective in adults with liver disease who have been untreated or who have failed previous therapy.  Protease inhibitors are commonly used to treat HIV infection. In the treatment of hepatitis C infection, boceprevir inhibits an enzyme, thereby suppressing replication of the hepatitis C virus.

Despite the committee’s affirmative vote, the advisors also had reservations about  boceprevir’s widespread usage.

via FDA Panel Urges Approval of Hepatitis C Drug.

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